EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 13 lipnja 2024. Database contains 4821 unique substances/entries.
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2-CHLORO-5-METHYLPYRIDINE; CMP
418-050-0
18368-64-4
Acute Tox. 4; Skin Irrit. 2
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
417-970-1
1379932-74-7
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1
ATRAC 869
417-960-5
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
FLUFENOXURON
417-680-3
101463-69-8
Lact.
5-CHLOR-2-PENTANON-NEOPENTYLKETAL; 5-CHLORO-2-PENTANONE-NEOPENTYLKETAL; CHLORKETAL
417-650-1
88128-57-8
STOT RE 2
NAVY DER 7850
417-640-5
161935-19-9
Eye Dam. 1; Skin Sens. 1
REACTIVE NAVY DER 7678
417-610-1
155522-09-1
Skin Sens. 1
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
EBO
417-540-1
-
Eye Dam. 1
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
PDN 2287
417-450-2
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
PD 133602-2
417-430-3
63645-17-0
Acute Tox. 3; STOT RE 2; Skin Sens. 1
FRESCOLAT MPC
417-420-9
156324-82-2
Eye Irrit. 2
X-17-17
417-410-4
61807-67-8
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
417-360-3
1379678-84-8
Acute Tox. 4; Skin Irrit. 2
EPIKURE DX 6906
417-350-9
776326-15-9
Skin Irrit. 2; Eye Dam. 1
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
FC4010
417-290-3
147086-81-5
Acute Tox. 4
BLACK UL 1253
417-280-9
30785-74-1
Eye Dam. 1
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
ATIPACL
417-220-1
37441-29-5
Skin Sens. 1
DAISO CCS-1S-E; S-GLYTO
417-210-7
70987-78-9
Carc. 1B; Muta. 2; Eye Dam. 1; Skin Sens. 1
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
417-130-2
1379689-21-0
Eye Dam. 1
TYZOR ZEC
417-110-3
1379678-99-5
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
1-DODECENE DIMER, HYDROGENATED; ALKANE 2
417-060-2
151006-61-0
Acute Tox. 4
417-050-8
151006-58-5
Acute Tox. 4
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
SPIRAMBRENE
416-930-9
121251-67-0
Skin Irrit. 2
TMAP
416-900-5
79723-02-7
Acute Tox. 3; STOT RE 2
DISPERSOL BLUE C-4G COLOUR; SUBSTANCE H87919
416-860-9
777891-21-1
Repr. 2; Skin Sens. 1
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
2,3,5,6-TETRAFLUROROBENZOIC ACID; SUBSTANCE TFBA
416-800-1
652-18-6
Skin Irrit. 2; Eye Dam. 1
1-BROM-3,5-DIFLUORBENZOL; 1-BROMO-3,5-DIFLUOROBENZENE; BDFB
416-710-2
461-96-1
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
BTAD
416-470-9
170292-97-4
Eye Irrit. 2
B8510-020; CHLORMETHYLPYRIDIN; CHLORMETHYLPYRIDINE; CHLOROMETHYLPYRIDINE
416-440-5
72830-09-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
DICHLORO-2,6 P.T.F.M.A.
416-430-0
24279-39-8
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
416-360-0
162221-28-5
Skin Sens. 1
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
DISPERSE RED CLA 282
416-240-8
155522-12-6
Skin Sens. 1
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
SQ 28,355; SQ 28355
416-050-5
87460-09-1
Eye Dam. 1

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